Kornimate/medical-research-clean huggingface dataset:
taste of medicines in children

Conditions: Medication Adherence; Medication Reaction

Summary: some but not all children will refuse to take medicine because of its taste, which can lead to substantial worsening of disease, antibiotic resistance, increased health care costs, and even death. the investigators are systematically assessing individual variation in the taste of liquid clindamycin among genotyped pediatric patients prescribed clindamycin for standard of care treatment, to determine whether (1) genetic variation underlies differences in taste ratings of the antibiotic; (2) initial taste responses, genetics, or both predict likelihood of side effects and medication non-adherence.

taste plays an integral role in whether a child accepts a medicine. some children will like the taste of a given medicine and complete the full course of treatment, whereas others will strongly reject its taste, suffer taste-modulated side effects, or both. this study will systematically measure initial palatability and reactions to the first dose of an antibiotic (clindamycin, liquid formulation) by pediatric patients who are receiving clindamycin as part of their standard of care treatment. saliva will be collected from all patients for gwas. taste response, tolerance of the medication, adherence and clinical outcomes will be assessed. subjects will be followed to determine if they complete the prescribed medication regimen (adherence) and/or experience side effects (tolerability). because medication-specific side effects have patient-specific variability, the investigators will determine whether the child's initial taste responses, genes, or both predict subsequent side effects and medication adherence.

Eligibility criteria:
inclusion criteria: * children age 3 to 12 * child being treated in children's hospital of philadelphia * being prescribed clindamycin liquid * parental/guardian permission (informed consent) and if appropriate, child assent * parent age 18 or older, or a minor permitted by state law to consent for their own participation and for the participation of their child * parent must have primary responsibility for the patient including biologic parents and adoptive parents (if legally allowed to consent to research) * parent must be english speaking and able to understand study materials exclusion criteria: * unwilling or unable to produce saliva sample

Keywords: pediatrics personalized medicine gwas taste side effects clindamycin
single and multiple ascending dose study of aducanumab (biib037) in japanese participants with alzheimer's disease

Conditions: Alzheimer's Disease

Summary: the primary objective of the study is to evaluate the safety and tolerability of single and multiple intravenous (iv) infusions of aducanumab in japanese participants with mild to moderate alzheimer's disease (ad). the secondary objectives of this study are as follows: to evaluate the serum pharmacokinetics (pk) of aducanumab after single and multiple intravenous (iv) infusions of aducanumab; to evaluate the effect of single and multiple iv infusions of aducanumab on immunogenicity.


Eligibility criteria:
key inclusion criteria: * must be ambulatory * must have a clinical diagnosis of mild to moderate ad * must be in good health as determined by the investigator, based on medical history and screening assessments * must have a caregiver who, understands the study and assents to accompany the subject to all study site visits, provide information to the investigator/study site staff, specifically about cognitive abilities and aes/saes and return for per-protocol follow-up visits and procedures * must consent to blood sample collection for deoxyribonucleic acid (dna; genotyping) and ribonucleic acid (rna; for potential future analysis). key exclusion criteria: * any medical or neurological condition (other than ad) that in the opinion of the investigator could be a contributing cause of the subject's dementia * transient ischemic attack or stroke or any unexplained loss of consciousness within 1 year prior to screening * poorly controlled diabetes mellitus, as defined by having dosage adjustment of diabetic medication within the 3 months prior to day 1 * history of unstable angina, myocardial infarction, chronic heart failure * chronic, uncontrolled hypertension * history of seizure within 3 years prior to screening * history within the past 6 months or evidence of clinically significant psychiatric illness * history of severe allergic or anaphylactic reactions, or history of hypersensitivity to any of the inactive ingredients in the drug product note: other protocol defined inclusion/exclusion criteria may apply
mobile application for bariatric surgery patients

Conditions: Obesity; Bariatric Surgery; Quality of Life; Complication; Mobile Health; EHealth; Self Management

Summary: introduction: one of the alternative ways, as a result of the increasing demand for health services and the inadequacy of meeting the increasing needs, is mobile health applications. according to tuik 2019 data, the rate of having mobile phones in households is 98.7%. with the development of technology, all information can be integrated into the mobile phone, and mobile applications allow the patient to give data from the environment in which he lives and to evaluate himself. self-assessment and monitoring of the patient enable the patient to participate in his/her self-care, supports self-management behaviors, and improves their quality of life. objective: it was aimed to develop a mobile support application for patients undergoing bariatric surgery and to evaluate the effect of application use on patients' self-management, quality of life, and clinical outcomes. method: in the first stage; * preparing the information to be included in the mobile health application that is planned to be developed and evaluating the quality of the content, * parallel to this, the adaptation of the "bariatric surgery self-management behaviors scale" into turkish and the evaluation of its validity and reliability. * design of the mobile application, transferring the educational content to the mobile application, * it is aimed to evaluate the technical suitability and usability of the mobile application. in the second stage, it was aimed to conduct a randomized controlled study to determine the effect of the developed mobile application on the self-management, quality of life and clinical outcomes of the patients. the developed mobile application will be introduced to patients at discharge after bariatric surgery. rating scales will be administered to patients at the end of one, three, and six months after surgery. these scales are the bariatric surgery self-management behaviors scale and the moorehead-ardelt quality of life scale-ii. conclusion: it is expected that the mobile application-based education to be developed for bariatric surgery will improve the patients' post-surgical self-management, increase their quality of life and decrease the early complication rates.


Eligibility criteria:
inclusion criteria: * speaking and understanding turkish, * being literate * having the ability to use a smartphone, * having a mobile phone with ios or android software, * having internet access, * having consented to download the mobile application to the mobile phone, * between the ages of 18-65, * patients undergoing bariatric surgery for the first time. exclusion criteria: * patients with vision or hearing problems
cyclization of motor cortex stimulation

Conditions: Neuropathic Pain

Summary: motor cortex stimulation (mcs) is a form of brain stimulation for patients with neuropathic pain not responsive to medication. an electrode is placed on the surface of the brain and connected to a programmable battery in the chest. the strength of stimulation can be individually adjusted by changing the voltage of stimulation. a too high voltage will produce side effects (e.g. seizures) while a too low voltage will not provide pain control. the aim of this study is to analyze the optimal stimulation timing parameters in patients already implanted with mcs and have received good pain relief. the investigators wish to cyclize on/off mcs in order to save the battery life of the stimulator and also decrease stimulus habituation. the investigators hope to determine these timing parameters while maintaining optimal pain relief.


Eligibility criteria:
inclusion criteria: * adult patient more than 18 years of age * chronic neuropathic pain effectively treated with motor cortex stimulation * stable medication during the trial * willing and able to comply with the study protocol and to return per the follow-up visit schedule and able to provide informed consent. exclusion criteria: * evidence of an active disruptive psychiatric disorder or other known condition significant enough to impact the perception of pain, compliance to intervention and/or ability to evaluate treatment outcome as determined by the investigator * technical malfunction of the mcs device * history of seizures * unable to provide informed consent
diagnostic performances of mandibular cbct in osteoporosis

Conditions: Osteoporosis

Summary: in the last decade, there has been a shift towards cone-beam computed tomography (cbct - regarding its low-dose radiation profile) in dentistry/implantology fields because it presents a more conclusive insight in the bone micro-architecture and cortical/trabecular bone structures assessment due to 3d acquisition higher resolution. despite convergent and interesting preliminary results, most cbct studies failed in highlighting a potential new osteoporosis diagnostic tool. tomosteop study aims to explore inter-relation between cbct parameters and dxa gold-standard parameters in order to build resolutive explicative model of bone mineral density and test cbct diagnostic performances.

in the last decade, there has been a shift towards cone-beam computed tomography (cbct - regarding its low-dose radiation profile) in dentistry/implantology fields because it presents a more conclusive insight in the bone micro-architecture and cortical/trabecular bone structures assessment due to 3d acquisition higher resolution. despite convergent and interesting preliminary results, most cbct studies failed in highlighting a potential new osteoporosis diagnostic tool. tomosteo aims to explore inter-relation between cbct parameters and dxa gold-standard parameters in order to build resolutive explicative model of bone mineral density and test cbct diagnostic performances. tomosteop study will analyze cbct and dxa acquisitions of \>65 years old post-menopausal women who performed contemporaneously (ie. maximum 3months delay) these 2 exams. radiomorphometric (i/s/ctmi/cti(s)/cti(i)), gray values (cortical and trabecular) and fractal dimension indexes will be measured on the whole mandibular arch, as well as cortical/trabecular thicknesses. correlations and odds-ratio will be calculated regarding dxa parameters and t-scores (-2,5ds). differences between osteopenic, osteoporotic and healthy women will be explored.

Eligibility criteria:
inclusion criteria: * \> 65 years old post-menauposal women * contemporanean (ie. 3months) cbct and dxa exams performed in nantes university hospital. exclusion criteria: * \< 65 years old post-menauposal women * cbct and dxa exams interval superior to 3months.
cognitive and emotional impairment after stroke

Conditions: Stroke; Cognitive Impairment; Vascular Dementia

Summary: cognitive and emotional symptoms are often seen in the acute phase of a stroke. the prevalence of such symptoms later and the mechanisms explaining the symptoms are not fully known. the causes of poststroke dementia are likely to be multifactorial (cerebrovascular diseases 2006). the investigators want to include all patients with first ever stroke without significant cognitive decline prior to the stroke (iqcode cut-off 3,7) and follow them up for one year. at baseline we will make stroke classifications, measure neurological deficits according to nihss, evaluate cognitive and emotional function and make registrations of vascular risk factors, including precerebral color duplex scan with measurement of imt in cca. the investigators will then randomize the patients into multifactorial vascular-risk-factor-intervention in the hospital or care as usual in the primary health care. 8-12 months after stroke onset, survivors will undergo new examinations to evaluate neurological, cognitive and emotional functions, as well as mri and spect.


Eligibility criteria:
inclusion criteria: * first ever stroke or tia * no cognitive decline (iqcode \< 3,7) * survived the acute stroke * expected to live at least for one year after stroke exclusion criteria: * cognitive decline

Keywords: emotional symptoms vascular risk-factors
utility of abdominal ultrasound in the evaluation of children with blunt trauma

Conditions: Abdominal Injuries

Summary: the major goal of this project is to conduct a randomized controlled trial studying an initial evaluation strategy with abdominal ultrasound versus a strategy without abdominal ultrasound for the evaluation of children with blunt abdominal trauma. the proposal's objectives are to compare the following variables in those that randomize to abdominal ultrasound versus those that do not: 1. rate of abdominal ct scanning 2. time to emergency department disposition 3. the rate of missed/delayed diagnosis of intra-abdominal injury 4. the costs.


Eligibility criteria:
inclusion criteria: * blunt torso trauma resulting from a significant mechanism of injury * motor vehicle collision: greater than 60 mph, ejection, or rollover * automobile versus pedestrian/bicycle: automobile speed \> 25 mph * falls greater than 20 feet in height * crush injury to the torso * physical assault involving the abdomen * decreased level of consciousness (glasgow coma scale score \< 15 or below age-appropriate behavior) in association with blunt torso trauma * blunt traumatic event with any of the following (regardless of the mechanism): * extremity paralysis * multiple long bone fractures (e.g., tibia and humerus fracture) * history and physical examination suggestive of intra-abdominal injury following blunt torso trauma of any mechanism (including mechanisms of injury of less severity than mentioned above) exclusion criteria: * no concern for inter-abdominal injury or no planned evaluation for possible iai * prehospital or ed age adjusted hypotension * prehospital or initial ed gcs score ≤ 8 * presence of an abdominal "seat belt sign" - continuous area of erythema/contusion completely across the lower abdomen secondary to a lap belt * penetrating trauma: stab or gunshot wounds * traumatic injury occurring \> 24 hours prior to the time of presentation to the ed * transfer of the patient to the ucdmc ed from an outside facility with abdominal ct scan, diagnostic peritoneal lavage, or laparotomy previously performed * patients with known disease processes resulting in intraperitoneal fluid including liver failure and the presence of ventriculoperitoneal shunts

Keywords: ultrasonography abdominal injuries trauma
adjunctive ganglionated plexus ablation in redo-pulmonary vein isolation

Conditions: Paroxysmal Atrial Fibrillation; Atrial Fibrillation

Summary: the investigator propose to test the efficacy of adjunctive et-gp ablation in patients undergoing redo pvi for paroxysmal af.

patients with ongoing paroxysmal arrhythmias after pulmonary vein isolation (pvi) for paroxysmal and persistent atrial fibrillation (af) get incrementally less benefit with redo-pvi. this implies non-pulmonary vein (pv) triggers, which are more challenging to locate. the autonomic nervous system is implicated in the multifactorial pathogenesis of af but few studies have attempted neural targeting as a therapeutic intervention. we have demonstrated that stimulation of specific left atrial ganglionated plexi (gps) triggers both af and atrial ectopy and importantly stimulation of these sites may not induce av block, the 'conventional' marker used to locate gps. having shown that these ectopy-triggering gp (et-gp) sites are anatomically stable and can be rendered inactive by either ablation at the site or by ablation between the site and the adjacent pv, a single centre study suggests that et-gp ablation can prevent recurrent af in some patients.

Eligibility criteria:
inclusion criteria: * males or females eighteen (18) to eighty five (85) years old * paroxysmal atrial fibrillation * previous pulmonary vein isolation * suitable candidate for catheter ablation * signed informed consent exclusion criteria: * contraindication to catheter ablation * presence of a cardiac thrombus * valvular disease that is grade moderate or greater * any form of cardiomyopathy * on amiodarone therapy * patients who lack capacity * active gastrointestinal bleeding * active infection or fever * renal failure (creatinine \>200µmol/l) * life expectancy shorter than the duration of the trial * bleeding or clotting disorders or inability to receive heparin * pregnant
a clinical trial of the effectiveness and safety of software assisting diagnose the intestinal polyp digestive endoscopy by analysis of colonoscopy medical images from electronic digestive endoscopy equipment

Conditions: Artificial Intelligence; Enteroscope; Intestinal Polyposis, Adenomatous

Summary: a clinical trial of the effectiveness and safety of intestinal polyp digestive endoscopy-assisted diagnosis software used in the analysis of colonoscopy medical images generated by electronic digestive endoscopy equipment.


Eligibility criteria:
inclusion criteria: * age of 18 to 85 years old, regardless of gender; * electronic colonoscopy is required; * the subjects or their legal representatives could understand the purpose of the trial, show sufficient compliance with the trial protocol, and sign the informed consent. exclusion criteria: * (1) contraindications associated with electronic colonoscopy or biopsy; * (2) poor intestinal preparation; * (3) diagnosed colorectal cancer, familial polyposis, or complicated with known colorectal polyps; * (4) serious neurological diseases or dysfunction of vital organs (heart, lung, liver, kidney); * (5) acute abdominal or intestinal inflammation; * (6) history of abdominal, pelvic, anal and perianal operations within 2 months before enrollment; * (7) participated in other interventional clinical trials within 1 month before enrollment; * (8) in the interest of subjects, the investigator considers that they should not participate in other conditions of the clinical trial.
colonisation efficacy of oral probiotic fast melt powder

Conditions: Microbial Colonization

Summary: to evaluate the colonisation efficacy (i.e. ability of the probiotic bacteria to remain in your mouth) of a fast melt powder that quickly dissolves in the mouth. the fast melt powder will contain a streptococcus salivarius probiotic and the study is to be done in healthy adults.

this is a double-blind, randomized controlled study with no cross over to evaluate the colonization efficacy of fast melt powders containing a commercially available probiotic bacterium streptococcus salivarius k12. participants will be randomly assigned to one of the 2 groups consuming fast melt powder containing two different doses of streptococcus salivarius k12 over a seven day period. saliva samples will be collected at predetermined time points pre and post intervention. colonization efficacy will be determined by enumerating the probiotic in the saliva samples using standard microbiological techniques.

Eligibility criteria:
inclusion criteria: 1. in general good health 18 - 80 years of age. 2. practice good oral hygiene. exclusion criteria: 1. have a history of autoimmune disease or are immunocompromised. 2. are on concurrent antibiotic therapy or regular antibiotic use within last 1 week 3. history of allergy (e.g. dairy).

Keywords: streptococcus salivarius k12 oral probiotic fast melt powder
continuous glucose monitoring during diets that differ in glycemic load

Conditions: Glucose Metabolism Disorders

Summary: this study test whether a continuous glucose monitor can pickup differences in glucose (in the interstitial fluid) during a dietary intervention using meals with either a high with a low glycemic load.

the aim of this study is to determine the suitability of a continuous glucose monitor to detect the impact of a dietary intervention on postprandial blood glucose levels in normal, healthy, free living subjects. we will compare a dietary intervention of meals with a high glycemic load (high post-meal blood glucose) versus meals with a low glycemic load (low post-meal blood glucose) in a cross-over study. in addition, the glucose profiles obtained both via venous blood sampling and via continuous glucose monitor following a standard carbohydrate load will be compared.

Eligibility criteria:
inclusion criteria: * apparently healthy males and post-menopausal females * age at start of the study ≥ 50 and ≤ 70 years * body mass index (bmi) ≥ 25.0 and ≤ 35.0 kg/m2 * fasting blood glucose value of subjects is ≥ 3.4 and \< 6.1 mmol/l at screening * being used to eat three meals a day * having a general practitioner * agreeing to be informed about medically relevant personal test-results by a physician * accessible veins on arms as determined by examination at screening. exclusion criteria: * having a medical conditions which might affect the study measurements (including but not limited to: diabetes type 1 and type 2, gastrointestinal disorders, gastrointestinal surgery and inflammatory diseases, as judged by the study physician * reported use of over-the-counter or prescribed medication or food supplements, which may interfere with study measurements as judged by the principal investigator * use of oral antibiotics in 40 days or less prior to the start of the study * reported participation in another nutritional or biomedical study 3 months before the screening or during the study * reported participation in night shift work 2 weeks prior to screening or during the study. night work is defined as working between mid-night and 6.00 am * reported intense sporting activities \> 2h/w. intense sporting activities are defined as those activities that cause a lack of breath which limits the ability to have a normal conversation * reported alcohol consumption \> 10 units/week (female) or \> 14 units/week (male) * reported use of any nicotine containing products in the 6 months preceding the study and willing to abstain from use of nicotine containing products during the study itself * reported dietary habits: medically prescribed diet, slimming diet, vegetarian * reported weight loss/gain (\> 3 kg) in the last 2 months before the study * being an employee of unilever or research departments in nutrim or the maastricht university medical centre (mumc+) collaborating in this study * known allergy or intolerance to food products. * blood donation in the past 3 months

Keywords: glucose continuous glucose monitor glycemic load dietary intervention
retrospective evaluation of lung pathology in subjects with covid-19

Conditions: COVID-19; COVID-19 Pneumonia

Summary: non-interventional, retrospective, multi-center, follow-up study evaluating the effect of c21 on lung pathology in subjects previously hospitalised with covid-19 and enrolled in the vp-c21-006 trial.

the study will collect available hrct scans obtained prior to, during treatment with c21 or placebo and up to 24 weeks after trial completion. hrct scans will be assessed for ground glass opacity, reticulation, band opacity, fibrosis and consolidation by a central, blinded hrct reader.

Eligibility criteria:
inclusion criteria: * written informed consent * previously included in the vp-c21-006 trial and received at least one dose of investigational medicinal product (imp) * available record of at least one hrct performed within 24 weeks after completion of vp-c21-006. exclusion criteria: * participation in another interventional trial during the historical period covered by this study that could interfere with the study objectives or evaluation